MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-27 for CONTIPLEX TUOHY * 331693 manufactured by B.braun Medical.
[2989728]
Device involved was a braun contiplex tuohy continuous nerve block set. Pt had to come back to the hospital because her perineural catheter was "cut" at home. The manufacturer was contacted to report problem. They have not received any other complaints with the catheter breaking but took the information from the psqi (patient safety & quality improvement) report and will monitor any future complaints.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2723086 |
| MDR Report Key | 2723086 |
| Date Received | 2012-08-27 |
| Date of Report | 2012-08-27 |
| Date of Event | 2012-04-03 |
| Report Date | 2012-08-27 |
| Date Reported to FDA | 2012-08-27 |
| Date Added to Maude | 2012-08-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTIPLEX TUOHY |
| Generic Name | CONTINUOUS NERVE BLOCK SET |
| Product Code | BXN |
| Date Received | 2012-08-27 |
| Model Number | * |
| Catalog Number | 331693 |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B.BRAUN MEDICAL |
| Manufacturer Address | 901 MARCON BLVD. ALLENTOWN PA 18109 US 18109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-27 |